维生素K_1注射液安全警戒信号的挖掘与评价  

Mining and evaluation of the safety alert signal of vitamin K_1 injection

作　　者：马雪英 熊代琴[2] 余永强 张翠玲 王二胜 滕亮[1,2] MA Xue-ying;XIONG Dai-qin;YU Yong-qiang;ZHANG Cui-ling;WANG Er-sheng;TENG Liang(Xinjiang Medical University,Urumqi 830000;The First Affiliated Hospital of Xinjiang Medical University,Urumqi 830054;Monitoring Center for Adverse Drug Reactions of Food and Drug Administration of Xinjiang Uygur Autonomous Region,Urumqi 830000)

机构地区：[1]新疆医科大学,乌鲁木齐830000 [2]新疆医科大学第一附属医院,乌鲁木齐830054 [3]新疆维吾尔自治区食品药品监督管理局药品不良反应监测中心,乌鲁木齐830000

出　　处：《中南药学》2019年第1期117-121,共5页Central South Pharmacy

基　　金：新疆维吾尔自治区药学会科研基金项目(编号:YXH201803)

摘　　要：目的探讨维生素K_1注射液所致不良反应的规律特点,挖掘和评价维生素K_1注射液安全警戒信号,分析临床实际使用情况,为临床合理安全应用提供参考。方法回顾性调取新疆维吾尔自治区药品不良反应监测中心2007-2017年使用维生素K_1注射液致不良反应的报告,分析维生素K_1注射液临床应用情况,评估出现不良反应的风险因素以及说明书安全性信息所涉及的严重ADR。结果新疆地区维生素K_1注射液使用警戒信号包括给药剂量、给药途径、临床适应证用药和患者自身因素等。结论基于对真实世界ADR信号研究有助于开展药物的安全性评价,临床医务人员应严格把握维生素K_1注射液的适应证及用法用量,特别是连续使用时应加强监测。Objective To determine the characteristics of adverse reactions(ADR) caused by vitamin K1 injection, to explore and evaluate the safety warning signal of vitamin K1 injection, and to provide reference for clinical rational application. Methods We retrospectively retrieved reports of ADR, caused by vitamin K1 injection in Xinjiang Uygur Autonomous Region Adverse Drug Reaction Monitoring Center from 2007 to 2017. Assessed the risk factors for ADRs and severe ADRs corresponding the safety information in the instructions. Results The warning signs of vitamin K1 injection included the dose, route of administration, clinical indications, and patients factors. Conclusion Real world study of ADR signals helps improve drug safety evaluation. Clinical medical staff should strictly follow the instructions of vitamin K1 injection before and during drug treatment, especially for continuous use, and the monitor of ADRs should be strengthened.

关 键 词：维生素K1注射液 严重药品不良反应 用药警示 

分 类 号：R95[医药卫生—药学]